BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8750980 · Received July 1, 2019

    Report

    Report Number
    2024168-2019-05273
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    August 15, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: MFR SITE - REG NUMBER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IN THE ABSENCE OF DEVICE RETURNED FOR ANALYSIS, A CONCLUSIVE CAUSE THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. ADDITIONALLY, UNUSED, STERILE DEVICES FROM THE SAME LOT NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS SUCCESSFULLY PERFORMED WITH NO MALFUNCTIONS OBSERVED.

    Additional Manufacturer Narrative · 0

    PATIENT CODES: 2199 LABELED NA. DEVICE CODES: 2921 LABELED 2920 LABELED. INTERNAL FILE NUMBER - 380004/2-1: DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EXEMPTION NUMBER E2019001 PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. B3, B6: DATE ESTIMATED. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL NEUROLOGY PROCEDURE. REPORTEDLY, DURING LIFTING OF THE FOOTPLATE LEVER, THERE WAS RESISTANCE FELT. THE FEET WOULD NOT PULL BACK TO OPPOSE THE WALL. PULSATILE FLOW DID NOT CEASE. AFTER RETRACTING THE FEET AND ATTEMPTING TO REPOSITION THE DEVICE, THERE WAS NO CHANGE. THE DEVICE WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543629 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 9041941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention